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Simdax (LEVOSIMENDAN)
Simdax (generic name: LEVOSIMENDAN) is a Moderate Risk QT Prolonging Agents drug. It is currently in Phase 3 development for Congestive heart failure.
Simdax works by binding to troponin C, increasing calcium sensitivity in cardiac muscle cells, allowing for improved heart function without increasing oxygen demand.
Simdax (levosimendan) is a medication used to treat conditions such as heart failure, left ventricular dysfunction, and acute decompensated heart failure. It has been studied in clinical trials for its effects on myocardial hemodynamics, particularly in the context of coronary artery bypass grafting and myocardial stunning.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Cardiovascular Phase 3 risk
-2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | LEVOSIMENDAN |
|---|---|
| Drug class | Moderate Risk QT Prolonging Agents |
| Target | Troponin C, slow skeletal and cardiac muscles |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
Think of it like a key that unlocks the heart muscle, allowing it to work more efficiently without using more energy. This helps the heart pump more effectively, especially in people with heart failure. By doing so, it helps the heart work better without putting too much strain on it.
Approved indications
- Congestive heart failure
Common side effects
- Lymphatic fistula
- Femoral hernia incarcerated
- Pancreatic steatosis
- Wound infection pseudomonas
- Arterial haemorrhage
- Seroma
- Tricuspid valve incompetence
- Aortic valve stenosis
- Haemarthrosis
- Tachyarrhythmia
- Hepatic cyst
- Inflammatory marker increased
Drug interactions
- High Risk QT Prolonging Agents
Key clinical trials
- Long-Term Open-Label Extension Study of Oral Levosimendan (PHASE3)
- LEVEL-2: LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF-2 (PHASE3)
- LEVosimendan to Improve Exercise Limitation in Patients With PH-HFpEF (PHASE3)
- Impact Of Using LevosemidanVersus DobutamineOn Right Ventricular Function In AdultPatients Undergoing Elective Valve Replacement Surgery
- Interest of Levosimendan in Reducing Weaning Failures of ExtraCorporeal Life Support - ECLS (PHASE3)
- Shorter Weaning From Invasive Ventilation With Levosimendan (PHASE4)
- Levosimendan in Acute Decompensated Heart Failure (PHASE2,PHASE3)
- Clinical Outcomes of Levosimendan Versus Dobutamine Versus Milrinone in Cases With Acute Decompensated Heart Failure With Impaired Renal Function
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Simdax CI brief — competitive landscape report
- Simdax updates RSS · CI watch RSS
Frequently asked questions about Simdax
What is Simdax?
How does Simdax work?
What is Simdax used for?
What is the generic name of Simdax?
What drug class is Simdax in?
What development phase is Simdax in?
What are the side effects of Simdax?
What does Simdax target?
Related
- Drug class: All Moderate Risk QT Prolonging Agents drugs
- Target: All drugs targeting Troponin C, slow skeletal and cardiac muscles
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Congestive heart failure
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing